Browse Device Recalls
394 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 394 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 394 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 20, 2022 | C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-7070... | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly,... | Class II | Baxter Healthcare Corporation |
| Sep 20, 2022 | Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For... | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly,... | Class II | Baxter Healthcare Corporation |
| Sep 20, 2022 | Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-711... | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly,... | Class II | Baxter Healthcare Corporation |
| Sep 20, 2022 | Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, R... | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly,... | Class II | Baxter Healthcare Corporation |
| Sep 20, 2022 | Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #... | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly,... | Class II | Baxter Healthcare Corporation |
| Sep 14, 2022 | Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142... | Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex... | Class II | Baxter Healthcare Corporation |
| Sep 14, 2022 | Prismaflex M Set: M150 (product code 109990). For use in providing continuo... | Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex... | Class II | Baxter Healthcare Corporation |
| Sep 14, 2022 | Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). Fo... | Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex... | Class II | Baxter Healthcare Corporation |
| Sep 14, 2022 | Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ... | Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex... | Class II | Baxter Healthcare Corporation |
| Sep 14, 2022 | Prismaflex HF20 Set (product code 109841). For use in providing continuous f... | Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex... | Class II | Baxter Healthcare Corporation |
| Sep 2, 2022 | Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code C... | Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barc... | Class III | Baxter Healthcare Corporation |
| Aug 9, 2022 | Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product C... | Firm noted an increase in customer reports of leaks. | Class I | Baxter Healthcare Corporation |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack, RE... | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack... | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100 | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, ... | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack... | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack,... | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 p... | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 14, 2022 | The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Cor... | There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets. | Class II | Baxter Healthcare Corporation |
| Jun 24, 2022 | Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03. | The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... | Class II | Baxter Healthcare Corporation |
| Jun 24, 2022 | Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02. | The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... | Class II | Baxter Healthcare Corporation |
| Jun 24, 2022 | Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01. | The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... | Class II | Baxter Healthcare Corporation |
| Jun 24, 2022 | Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03. | The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... | Class II | Baxter Healthcare Corporation |
| Jun 24, 2022 | Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04. | The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... | Class II | Baxter Healthcare Corporation |
| Jun 24, 2022 | Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01. | The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... | Class II | Baxter Healthcare Corporation |
| Jun 24, 2022 | Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P79... | The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... | Class II | Baxter Healthcare Corporation |
| Jun 22, 2022 | ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: ... | There is a potential risk of medication error when using specific Abacus Order Entry & Calculatio... | Class I | Baxter Healthcare Corporation |
| May 31, 2022 | NaviCare Nurse Call/Voalte Nurse Call | An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, C... | Class II | Baxter Healthcare Corporation |
| May 17, 2022 | #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W... | Packaging error. | Class II | Baxter Healthcare Corporation |
| Apr 26, 2022 | In-Line ventilator adaptor | There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara s... | Class I | Baxter Healthcare Corporation |
| Apr 26, 2022 | In-Line ventilator adaptor | There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara s... | Class I | Baxter Healthcare Corporation |
| Apr 21, 2022 | Effluent Sample Bag | Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distribut... | Class II | Baxter Healthcare Corporation |
| Apr 21, 2022 | 5 Prong Manifold Set (with Luer Connectors) | Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distribut... | Class II | Baxter Healthcare Corporation |
| Apr 21, 2022 | Locking Cap for PD Catheter Adapter | Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distribut... | Class II | Baxter Healthcare Corporation |
| Apr 21, 2022 | APD Drain Manifold | Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distribut... | Class II | Baxter Healthcare Corporation |
| Apr 21, 2022 | 15 Liters Drain Bag | Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distribut... | Class II | Baxter Healthcare Corporation |
| Apr 21, 2022 | 3,65 m Extension Set with Luer-lock Connector | Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distribut... | Class II | Baxter Healthcare Corporation |
| Apr 13, 2022 | NaviCare Nurse Call System provides a comprehensive communication and info... | Firm discovered a firmware memory leak with a supplier-manufactured component. | Class II | Baxter Healthcare Corporation |
| Apr 13, 2022 | Voalte Nurse Call System provides a comprehensive communication and inform... | Firm discovered a firmware memory leak with a supplier-manufactured component. | Class II | Baxter Healthcare Corporation |
| Apr 1, 2022 | Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular p... | There is a potential for foreign matter. | Class II | Baxter Healthcare Corporation |
| Mar 15, 2022 | PrisMax System, Product Code 955626 | This correction is due to software anomalies occurring during use. If the operator initiates ther... | Class II | Baxter Healthcare Corporation |
| Mar 15, 2022 | PrisMax System, Product Code 955724 | This correction is due to software anomalies occurring during use. If the operator initiates ther... | Class II | Baxter Healthcare Corporation |
| Mar 15, 2022 | PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701 | This correction is due to software anomalies occurring during use. If the operator initiates ther... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H9386... | Product is mislabeled as self-righting Luer slip tip caps, yellow. | Class II | Baxter Healthcare Corporation |
| Feb 25, 2022 | MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C448... | Devices distributed lacked regulatory clearance. | Class II | Baxter Healthcare Corporation |
| Feb 21, 2022 | Liko Universal Twinbar 670 QRH, an accessory that can be used together with m... | An incorrect center bolt was used in the assembly of the product which could result in a patient ... | Class II | Baxter Healthcare Corporation |
| Feb 14, 2022 | Compella Bariatric Bed System | Potential damage to the power cord may cause the power conductors to be exposed, thereby creating... | Class II | Baxter Healthcare Corporation |
| Feb 14, 2022 | Compella Therapy Air Supply Unit | Potential damage to the power cord may cause the power conductors to be exposed, thereby creating... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482 | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.